1. Office of Food Safety and Recall Food Safety Investigation and Recall Presented by: Francis Lindsay, CFIA Technical Specialist Querétaro, México, October 2-3, 2013

2. 2 Office of Food Safety and Recall Created in 1999 Mandate National coordination of food safety investigations and recalls Coordination of referred food safety investigations Contact point with Health Canada for health risk assessments Consistency of decision making Ensure service standards (timeliness) are met Single point of contact for international food emergency offices

3. 3 Office of Food Safety and Recall (OFSR) Guiding Principles Timeliness Appropriateness Consistency Thoroughness

4. 4 CFIA Partners in Food Recalls Policy and Program’s Branch Operations’ Strategy and Delivery Legal Services Public Affairs – Programs Communication Operations’ Enforcement and Investigation Services Science Branch’s Laboratories

5. 5 Recall Terminology Voluntary Recall (Non-Mandatory): A recall that is initiated and carried out by the recalling firm without ministerial order. Mandatory Recall: A recall as per Section 19 of the Canadian Food Inspection Agency Act. Recall Classification: The numerical designation, i.e. Class I, Class II or Class III, assigned by the OFSR to a particular product recall to indicate the relative degree of health risk presented by the product being recalled.

6. 6 Classes of Recalls Class II Class III Class I Temporary adverse health consequences or probability of serious adverse health consequences is remote Not likely to cause any adverse health consequences Regulatory Violation Serious adverse health consequences, possibly even fatal Public Alert may be issued No Public Alert Public Alert is usually issued

7. 7 Section 19 (1) Where the Minister believes on reasonable grounds that a product regulated under an Act or provision that the Agency enforces or administers by virtue of Section 11, poses a risk to public, animal or plant health, the Minister may, by notice or distributing the product, order that the product be recalled or sent to a place designated by the Minister. (2) Any person who contravenes a recall order referred to in subsection (1) is guilty of an offence and liable on summary conviction to a fine not exceeding $50,000 or to a term of imprisonment not exceeding six months or to both CFIA Act - Legislation – Recall Orders

8. 8 The Recall Process (Steps or Phases) Trigger Recall Implementation Recall Effectiveness Verification Corrective Action/ Follow-up Health Risk Assessment Food Safety Investigation Recall Decision-making

9. 9 Triggers Consumer and trade complaints Food borne illness outbreaks Firm self-initiated recalls and product withdrawals Referrals from CFIA programs CFIA audit or plant/product inspection findings Investigative/unsatisfactory laboratory analysis Referrals from other government departments Information from other countries (recalls) Media Internet/CFIA Webmaster Politicians Associations

10. 10 Goals To determine whether a hazard exists and the nature and extent of the problem To gather and verify the accuracy and completeness of information required for a Health Risk Assessment (CFIA and Company data) Ensure problem no longer exists and that it does not re-occur On-site Activities Understanding the process Observing practices and reviewing documented procedures Observing / inspecting equipment and conditions Verifying the accuracy and completeness of information Identifying cause of the problem and corrective actions required Scoping the problem (when it started / ended) Collecting samples where appropriate Food Safety Investigations

11. 11 Tracing the Food (Root Cause) FOODCHAINFOODCHAIN Origin Consumer Product Trace back Trace forward Brand Common Name Code UPC Label Package Date of purchase Store Other

12. 12 Health Risk Assessment / Decision Making OFSR compiles and assesses investigation findings / information, and requests a formal health risk assessment Health Canada is responsible for health risk assessments (HRA) for other cases The Executive Director of the OFSR will determine the type of risk management strategy, including recall, required to mitigate the health risk The firm is requested to initiate a voluntary recall to the appropriate level; distributor, retailer or consumer

13. 13 Basis for a recall Based on a Health Risk Assessment from Health Canada May be based on an Epidemiological Assessment from the Public Health Agency of Canada Company initiated recall Recall Decision

14. 14 Decisions will take into account other factors; for example: susceptible population product distribution availability at the consumer’s home Most are voluntarily recalls conducted by the industry Most are voluntarily recalls conducted by the industry Approximately 40% of recalls are company initiated Approximately 40% of recalls are company initiated Minister may order industry to conduct a recall; Mandatory recall Minister may order industry to conduct a recall; Mandatory recall Recall Decision

15. 15 Decision-Making Challenges Determination of depth of recall: warehouse, retail or consumer Timing – When do we proceed with a recall and issuing the alert Press releases for Class II recalls Press releases in other countries where product has been shipped to Canada Press releases for (HR 1) assessments where product is no longer at retail but likely in consumers homes Investigations and assessments outside the recall process Multiple recalls due to the expansion of the food safety investigation

16. 16 Implementation Where it is determined that the appropriate risk management strategy is to recall the affected product: the recalling firm is requested to conduct the recall CFIA monitors the recall process of the recalling firms Alerts are used by the CFIA and industry to communicate recalls to the consumer: press release identifying the affected product (s) press release is posted on the CFIA website and sent out to a subscriber e-mail list CFIA contacts federal / provincial counterparts and other countries as necessary

17. 17 Communication Press / News Release Templates Translation Service Release to News Media Posting on CFIA website Food Investigation Response Manual Recall Guides (4) Recall statistics

18. 18 Verification CFIA officials conduct effectiveness checks to verify that the recalling firm has recalled the product effectively CFIA, on occasion, may request the assistance of officials from provincial and territorial governments in conducting recall effectiveness checks If the recall is determined to be ineffective the CFIA will request the firm to redo the recall or issue a recall order, if required If a firm is unwilling to remove the product from sale and appropriately dispose of it, the CFIA may seize and detain the product

19. 19 Follow Up Monitor a company’s corrective action to prevent reoccurrence of the food safety hazard and potential subsequent recalls May require the review of standards and policies to determine whether changes are necessary Work with industry sectors or foreign countries to address trends that go beyond one company or sector

20. 20 Goals - timeliness, appropriateness, consistency, thoroughness Centre of Expertise (Office of Food Safety and Recall) Delegated authority / independence Mandatory recall authority Food borne Illness Outbreak Response Protocol (FIORP) Outbreak Investigation Coordination Committee Best Practices from the Canadian Model (1)

21. 21 Incident Command System for emergencies and high profile issues Food safety investigation process Recall effectiveness verification Part of an international network Issues Management System Best Practices from the Canadian Model (2)

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